Premarket Approval 101: A Comprehensive Guide to The PMA Process for Medical Devices

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What is Premarket Approval?

The U.S. Food and Drug Administration (FDA) uses a process called premarket approval (PMA) to evaluate the safety and effectiveness of Class III medical devices. These devices are critical in preserving or prolonging human life, significantly contribute to preventing impairment of human health, or carry a potential risk of illness or injury that is unreasonable.

Because of the high level of risk associated with Class III medical devices, the PMA pathway is the most rigorous approval process for medical devices by the FDA. The PMA process involves a comprehensive scientific and regulatory review of the medical device. The applicant must provide valid scientific evidence to demonstrate the device’s safety and effectiveness for its intended use(s). The FDA will then review the data submitted by the applicant, which may include clinical trial results, nonclinical testing data, and manufacturing information.

Once the FDA approves the PMA application, the device can be marketed for its intended use(s). It’s important to note that the PMA process is the most rigorous and time-consuming regulatory pathway for medical devices by the FDA. It typically takes several years for a medical device to complete the PMA process and receive FDA approval.

What are the different methods?

There are 4 different PMA submission methods that medical device manufacturers can apply: Traditional PMA, Modular PMA, Product Development Protocol, and Humanitarian Device Exemption.

Traditional PMA

A Traditional PMA is the most common PMA submission method. This method requires the submission of a complete PMA application as a single package and is typically used by manufacturers who have already completed clinical testing. It requires a comprehensive scientific and regulatory review of the device, including the submission of numerous volumes of materials such as device description, intended use, nonclinical and clinical study data.

Modular PMA

The Modular PMA is used for medical devices that are in the early stages of clinical studies which is recommended by the FDA. This method allows the applicant to submit a PMA application in modules, each addressing specific aspects of the device and required submission content. The FDA reviews each module as it is submitted, reducing the time and cost required for the complete PMA application to be reviewed. This approach is typically used for complex medical devices that require extensive testing , data analysis, and have not yet completed clinical testing. The FDA states that leveraging the modular PMA submission process it is not appropriate when the applicant is very close to being ready to submit a complete PMA or when the device design is in a state of flux or likely to change. Additional information on Modular PMA can be found in the Premarket Approval Application Modular Review guidance document.

Product Development Protocol

The Product Development Protocol (PDP) PMA method is used for medical devices that are still in the early stages of development and utilized for well-established technology. The PDP PMA method is designed to facilitate collaboration between the manufacturer and the FDA to optimize the device’s development and clinical testing. It allows the manufacturer to obtain agreement on the design and development activities early in the development process. The FDA reviews information as it is submitted, providing feedback to the manufacturer to ensure the device meets the FDA’s regulatory requirements. In contrast to the Modular PMA method which requires modules be fully complete and submitted in a specific order, the PMA Method allows the manufacturer to submit information as they become available to solicit FDA feedback and collaboration.

Humanitarian Device Exemption

This method is intended for devices that treat or diagnose diseases or conditions affecting fewer than 8,000 people in the United States per year. The HDE process is less rigorous than the traditional PMA process and requires the submission of clinical data demonstrating the device’s safety and probable benefit (ie, HDE is exempt from the effectiveness requirements specified in Section 514 and 515 of the FD&C Act and is subject to certain profit and use restrictions. If approved, the device can be marketed to treat or diagnose rare diseases or conditions. Additional information on HDE can be found in the Humanitarian Device Exemption guidance document.

PMA Submission Process

PMA Submission Content

To meet the requirements for Premarket Approval (PMA) of medical devices, the applicant must comply with the regulations set out in 21 CFR part 814.20. This includes providing detailed information such as device description, alternative practices and procedures, summary of clinical and nonclinical data, marketing history, and more. If the applicant determines that some of the information required under §814.20(b) is not applicable to their device and chooses to omit it from their PMA submission, they must provide a statement that explains the omitted information and provides a justification for why it is not necessary to include. More information on the PMA application content can be found under PMA Application Contents on the FDA website.

A submission for a Humanitarian Device Exemption (HDE) PMA requires the applicant to provide detailed information on the device’s description, intended use, safety and effectiveness data, manufacturing information, and labeling stated in the regulation 21 CFR 814.104. The submission must also include a certification that the device is intended to treat or diagnose a disease or condition that affects fewer than 8,000 individuals in the US per year, and as that there are no other comparable devices available to treat or diagnose the condition. Additionally, the submission should include information on how the device benefits patients in terms of safety and effectiveness and how the potential risks of using the device are mitigated. More information on HDE can be found on the following FDA webpage, Humanitarian Device Exemption.

Submission of PMA

A PMA submission must be submitted in an electronic format known as eCopy. An eCopy is an electronic version of the medical device submission that is created and submitted on a CD, DVD, or flash drive. The submission should be accompanied by a paper copy of a signed cover letter. The eCOPY Program for Medical Device Submissions guidance document provides detailed information on the eCopy format. Depending on the submission type, a PMA user fee may be required before submission. However, HDE applications are exempted from user fees. The User Fees and Refunds for Premarket Approval Applications and Device Biologics License Application guidance document provides detailed information on the PMA user fee.

PMA Submission Review

The FDA breaks down the PMA submission review in a four-step review process consisting of:

administrative and limited scientific review by FDA staff to determine completeness (acceptance and filing reviews)
in-depth scientific, regulatory, and Quality System review by appropriate FDA personnel (substantive review);
review and recommendation by the appropriate advisory committee (panel review); and
final deliberations, documentation, and notification of the FDA decision

Details on the FDA review process for PMA submission can be found under PMA Review Process on the FDA website.

Why Choose Innovenn for Your Premarket Approval (PMA) Services?

The Premarket Approval process can be complex and time-consuming, but it is essential for ensuring the safety and effectiveness of higher risk medical devices before they are marketed and sold to the public. At Innovenn, we understand the challenges of navigating the PMA process, and we are here to help. We have the expertise and resources to guide you through the PMA process and bring your medical device to market.

Our team of experts can help you with every step of the PMA process, from data collection and submission to clinical trials and FDA interactions. We understand the importance of getting your device to market as quickly and efficiently as possible, which is why we work closely with you to ensure that your submission is complete, accurate, and meets all FDA requirements.

To learn more about Innovenn’s Premarket Approval (PMA) services, contact us to discuss your specific needs.

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